DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution

2. What you need to know before you are given Dexmedetomidine Kabi

Dexmedetomidine Kabi must not be given to you:

• if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart rhythm disorders (grade 2 or 3 heart block).
• if you have very low blood pressure that does not respond to treatment.
• if you have recently had a stroke or other severe episodes that affect blood supply to the brain.

Warnings and precautions

Before using this medicine, tell your doctor or nurse if you are in any of the following situations, as Dexmedetomidine Kabi should be used with caution:

• if you have an abnormally slow heart rate (either due to disease or a high level of physical fitness) as it may increase the risk of cardiac arrest
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• if you have certain heart diseases
• if you are elderly
• if you have a neurological disorder (e.g. head or spinal cord injuries or stroke)
• if you have severe liver problems
• if you have ever developed a severe fever after some medicines, especially anesthetics

This medicine may cause a large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or younger when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease upon admission to the intensive care unit and with younger age. Your doctor will decide if this medicine is still suitable for you. Your doctor will consider the benefits and risks of this medicine for you, compared to treatment with other sedatives.

Other medicines and Dexmedetomidine Kabi

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines may increase the effect of Dexmedetomidine Kabi:

• medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
• medicines for severe pain (e.g. opioids such as morphine, codeine)
• anesthetic medicines (e.g. sevoflurane, isoflurane)

If you are using medicines that lower your blood pressure and heart rate, taking them with Dexmedetomidine Kabi may increase this effect. Dexmedetomidine Kabi should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Dexmedetomidine Kabi should not be used during pregnancy or breastfeeding, unless clearly necessary.

Driving and using machines

Dexmedetomidine Kabi has a major impact on the ability to drive and use machines. Once you have been given Dexmedetomidine Kabi, you should not drive, operate machinery or work in hazardous situations until the effects have passed completely. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidine Kabi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially 'sodium-free'.

3. How Dexmedetomidine Kabi is given

Intensive care in hospital

This medicine is given to you by a doctor or nurse in the intensive care unit of a hospital.

Procedural sedation/conscious sedation

Dexmedetomidine Kabi is given to you by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, e.g. procedural sedation/conscious sedation.

Your doctor will decide the right dose for you. The amount of Dexmedetomidine Kabi depends on your age, body weight, overall health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine Kabi is diluted and given to you as an infusion (drip) into your veins.

After sedation/waking up

• Your doctor will keep you under supervision for a few hours after sedation, to make sure you are well.
• You should not go home unless accompanied.
• Medicines that help you sleep, cause sedation and those intended to relieve severe pain may not be recommended for a period of time after treatment with Dexmedetomidine Kabi. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexmedetomidine Kabi

If you have been given too much Dexmedetomidine Kabi, your blood pressure may go up or down, your heart beats may be slower, you may breathe more slowly and you may feel sleepier. Your doctor will know how to treat you based on your condition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or stopping breathing.

Common (may affect up to 1 in 10 people)

• chest pain or heart attack
• fast heart rate
• low or high blood sugar levels
• nausea, vomiting or dry mouth
• restlessness
• high temperature
• symptoms after stopping the medicine.

Uncommon (may affect up to 1 in 100 people)

• reduced heart function, cardiac arrest
• stomach swelling
• thirst
• a condition where there is too much acid in the body
• low albumin levels in the blood
• difficulty breathing
• hallucinations
• the medicine is not effective enough.

Rare (may affect up to 1 in 1,000 people)

• large amount of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dexmedetomidine Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use if the vial is damaged or broken.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Dexmedetomidine Kabi

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The other ingredients are sodium chloride and water for injections.

Each 2 ml vial contains 200 micrograms of dexmedetomidine.

Each 4 ml vial contains 400 micrograms of dexmedetomidine.

Each 10 ml vial contains 1000 micrograms of dexmedetomidine.

The concentration of the final solution after dilution should be 4 micrograms/ml or 8 micrograms/ml.

Appearance and packaging

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution.

Packaging

2 ml, 4 ml or 10 ml glass vials

Pack sizes

10 vials of 2 ml

25 vials of 2 ml

1 vial of 4 ml

4 vials of 4 ml

10 vials of 4 ml

4 vials of 10 ml

10 vials of 10 ml

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

Marina 16-18, 08005 - Barcelona

Spain

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36, 8055 - Graz

Austria

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: October 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

<------------------------------------------------------------------------------------------------------------------------>

This information is intended only for healthcare professionals:

Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion EFG

Method of administration

Dexmedetomidine Kabi should be administered by healthcare professionals experienced in the management of patients who require intensive care or in the anaesthetic management of patients in the operating room. It should be administered only as an intravenous infusion diluted using a controlled infusion device.

Dexmedetomidine Kabi can be diluted in the following infusion solutions to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration:

• Sodium chloride 9 mg/ml (0.9%)
• Glucose 50 mg/ml (5%)
• Ringer's solution
• Lactated Ringer's solution
• Manitol 200 mg/ml (20%)

See below for the volumes needed to prepare the infusion in a table.

In case a concentration of 4 micrograms/ml is required:

In case a concentration of 8 micrograms/ml is required:

The solution should be gently shaken to mix well.

Dexmedetomidine Kabi should be inspected visually for particles and coloration before administration.

Dexmedetomidine has been shown to be compatible when administered with the following intravenous fluids and medicines:

Lactated Ringer's solution, glucose 5% solution, sodium chloride 0.9% solution, mannitol 20% solution, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

Shelf life

Chemical and physical stability in use has been demonstrated for 24 hours at 25 °C and for 24 hours between 2 °C and 8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be longer than 24 hours at 2-8°C, unless the dilution has been made in aseptic and controlled conditions.